Anti-tartar dental product and method

ABSTRACT

An oral product and method is provided for inhibiting tartar formation on the teeth. The product is housed in a container and includes a first composition containing a water soluble calcium phosphate salt or monolithic combination of calcium and phosphate salts in a carrier with the first composition having a pH less than 7, and a second composition containing an alkaline material and a fluoride ion source in a carrier to achieve a pH greater than 7.5. The first and second compositions are separated from one another prior to use. When combined upon application to the teeth, the first and second compositions form a system for inhibiting tartar around the teeth.

This is a Divisional application of Ser. No. 09/395,064 filed Sep. 13,1999, which arises from U.S. Provisional Application Serial No.60/129,779 filed Apr. 16, 1999.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to new anti-tartar systems, dentifricecompositions containing these systems and their use in controllingtartar accumulation on teeth.

2. The Related Art

Tartar, known also as calculus, is a hard mineralized deposit whichforms around teeth. This formation arises from deposition of crystals ofcalcium phosphate in the pellicle and the extracellular matrix of dentalplaque. Various forms of calcium phosphate have been identified but themost difficult to remove and thermodynamically most stable form iscalled hydroxyapatite (HAP). Amorphous forms of calcium phosphate arebelieved to be the precursors of HAP. Regular brushing can usuallyremove the amorphous forms but is not fully effective to dislodge thefinal stable calculus form. Therefore it is desirable to preventamorphous forms of calcium phosphate from transforming into HAP. The arthas recognized that agents which interfere with the formation of HAPcrystallization will be effective anti-tartar agents.

Soluble inorganic pyrophosphate salts have over the last decade set thecommercial standard as tartar control agents. This technology has beenreported by Parran, Jr. et al. in a series of patents including U.S.Pat. No. 4,590,077, U.S. Pat. No. 4,515,772 and U.S. Pat. No. 4,684,518.

Anionic polymers, especially carboxylate group functionalized polymershave been widely reported as effective against calculus. Commerciallymost significant has been the use of synthetic, linear anionic polymersof higher molecular weight in combination with the inorganicpyrophosphates. This technology derives from work done by Gaffar et al.reported in a series of patents including U.S. Pat. No. 4,627,977, U.S.Pat. No. 4,806,340, U.S. Pat. No. 4,806,342, U.S. Pat. No. 4,808,400 andU.S. Pat. No. 4,808,401. Anionic polymers described therein were foundto inhibit the action of pyrophosphatase in the mouth and thereforeallowing greater efficacy of the inorganic pyrophosphate. Thecommercially operative polymer is a methyl vinyl ether/maleic anhydridecopolymer, available under the GAF trademark Gantrez.

Organic phosphonic acid derivatives, some in polymeric form, have beendisclosed in U.S. Pat. No. 3,934,002 (Haefele). EP 0 341 662 (Amjad)cites a tartar inhibiting oral composition that includes a fluoridesource, a dental abrasive, a carboxylate polymer and various phosphonicacids and their derivatives. A phosphated acrylic acid/hydroxyethylmethacrylate/alkyl methacrylic acid ester copolymer has been suggestedin GB 2 139 635B (Causton) as useful in an oral composition for treatingteeth.

Evident from the foregoing review of the art is the considerable effortexpended to devise better tartar control compositions. By no means,however, has any of the reported art been able to more than attenuatethe problem. There is considerable room for improvement over the knowncontrol agents.

Accordingly, it is an object of the present invention to provide aproduct of improved efficacy in controlling formation of tartar.

A still further object of the present invention is to provide a tartarcontrol product of improved taste, safety and appearance.

These and other objects of the present invention will become moreapparent in light of the detailed description and Examples which follow.

SUMMARY OF THE INVENTION

An anti-tartar dental product is provided comprising:

(i) a container;

(ii) an oral composition stored within the container, the compositionincluding:

(a) a first composition comprising from about 0.01 to about 30% byweight of a water-soluble calcium phosphate or monolithic combination ofwater soluble calcium and phosphate salts, the composition having a pHless than 7; and

(b) a second composition including from about 0.01 to about 30% byweight of an alkaline material and an anti-caries effective amount of afluoride ion source, the second composition having a pH greater than 7.5and stored separately from the first composition in a manner to avoidcontact between the phosphate and the alkaline material;

(iii) instructions printed on the container directing use of thecomposition to control tartar when applied to the teeth.

A method is provided for controlling dental tartar which includes:

(i) obtaining a product which includes:

(a) a first composition comprising from about 0.01 to about 30% byweight of a water-soluble calcium phosphate or monolithic combination ofwater soluble calcium and phosphate salts, the composition having a pHless than 7; and

(b) a second composition comprising from about 0.01 to about 30% byweight of an alkaline material and an anti-caries effective amount of afluoride ion source, the second composition having a pH greater than 7.5and stored separately from the first composition in a manner to avoidcontact between the phosphate and the alkaline material;

(ii) extruding a portion of first and second compositions onto atoothbrush; and

(iii) brushing the teeth with the combination of first and secondcompositions.

DETAILED DESCRIPTION OF THE INVENTION

Products intended for remineralization of teeth ordinarily employcalcium and phosphate ions. Naturally there is great concern that theseions can be diverted from remineralization to calculus forminghydroxyapatite. Now it has been discovered that when a water solublecalcium phosphate salt is stored within one composition held at a low pHand mixed after storage with a second composition having a high pH, theresult is a significant reduction in normal tartar formation against theteeth.

Separate storage of the two compositions of this invention may beaccomplished through a dual compartment dispenser. U.S. Pat. No.4,687,663 (Schaeffer) discloses a dual-compartment package respectivelystoring a peroxide gel and a bicarbonate paste. Pump packaging withmultiple compartments is reported in U.S. Pat. No. 5,038,963 (Pettengillet al.) and U.S. Pat. No. 5,020,694 (Pettengill) which are embodied in aU.S. product known as Mentadent® Baking Soda & Peroxide toothpaste.

Of course, delivery of compositions according to the present inventionis not limited to unitary albeit multicompartmented dispensers nor tototally segregated compartments. The dispenser may be a system in theform of two individual tubes quite separate from one another butpackaged within a kit. Ribbons of the dentifrice from each tube aredelivered to a toothbrush with mixing of the compositions occurring inthe mouth. Delivery may also be from a single chambered tube except thateach of the two compositions are semi solid strips positionedside-by-side touching but not mixing with one another. The relativelyhigh viscosity of the products prevents any substantial transference ofeither pH change or components between the two strips. Illustrative ofthis technology is a U.S. product sold by Colgate® under the Baking Soda& Peroxide brand. Still another method of delivery may be a singlecomposition such as a paste or gel housing an alkaline environment.Monocalcium phosphate compositions may be dispersed throughout thealkaline composition yet separated from contact by a coatingencapsulating the phosphate. Activation occurs in the mouth through thepresence of water or saliva which penetrates the encapsulating coatingreleasing phosphate salt to interact with the alkaline environment.

A critical component of the first composition of this invention is awater soluble calcium phosphate salt. By the term “water soluble” ismeant a solubility of at least 0.1 gram in 100 ml water at 25° C. Mostpreferred is monocalcium hydrogen phosphate but also of potential useare calcium polyol phosphates (e.g. calcium glycerophosphate) andmonocalcium ammonium phosphate salts. Monolithic compositions of watersoluble calcium and phosphate salts may be employed as alternatives topre-formed water soluble calcium phosphates. By the term “monolithic” ismeant separate water soluble calcium salts and phosphate salts whichfrom solution may metathesize into calcium phosphates in solution orlater upon mixing with the second composition. Illustrative calciumsalts include the halides, sulphates, nitrates, citrates, sugars andC₁-C₆ carboxylates. Most preferred is calcium chloride, calcium sulphateand calcium acetate. The monolithic partner phosphate salts may bealkali, ammonium or combination salts thereof. Examples include sodiumammonium phosphate, sodium phosphate, ammonium phosphate and potassiumphosphate. The water-soluble calcium phosphate salts or the monolithiccalcium and phosphate salts (by weight of calcium and phosphate ionsonly) may be present in amounts ranging from 0.01 to 30%, preferablyfrom 0.1 to 20%, optimally from 1 to 10% by weight of the firstcomposition.

Solubility of the phosphate salt is maintained in the first compositionby having an acidic environment. The pH will be less than 7, preferablyfrom 1 to 6.5, more preferably from 1.8 to 6, optimally from 2.5 to 5.5.

The second composition of the present invention requires an alkalinematerial so that the second composition has a pH greater than 7,preferably from 7.2 to 11, more preferably from 8 to 10, optimally from8.5 to 9.5. Alkaline materials suitable to achieve the pH are sodiumbicarbonate, potassium bicarbonate, sodium carbonate, potassiumcarbonate, calcium carbonate, calcium oxide, sodium hydroxide, potassiumhydroxide and mixtures thereof. Amounts of the alkaline material mayrange from 0.1 to 60%, preferably from 0.5 to 30%, more preferably from1 to 20%, optimally from 3 to 15% by weight of the second composition.

Advantageously, compositions of this invention, especially the secondcomposition may contain a fluoride anti-caries compound. Illustrative ofsuch fluoride compounds are sodium fluoride, potassium fluoride, calciumfluoride, magnesium fluoride, stannous fluoride, stannousmonofluorophosphate, sodium monofluorophosphate and copper fluoride.Most preferred is sodium fluoride. These sources should release anywherefrom about 25 to about 5,000 ppm of fluoride ion. The anti-cariescompound will normally be present in an amount from about 0.01 to about5%, preferably from 0.1 to 2.5%, optimally from 0.2 to 1.5% by weight ofcombined first and second compositions.

The compositions of the present invention may be in the form of either atoothpaste, gel, powder or mouthwash. Most preferably the compositionsare either pastes or gels. Especially suitable is where the phosphatesalt is incorporated in a gel and the alkaline material incorporatedinto a paste. These compositions may include water or be anhydrous.

The phosphate salt as well as the alkaline material will be deliveredthrough a pharmaceutically acceptable carrier. The term“pharmaceutically acceptable carrier” will include such functionalingredients as water, humectants, abrasives, thickeners, surfactants andcombinations thereof. Total levels of these materials may range anywherefrom about 1 to about 99%, preferably from 20 to 80%, optimally from 30to 60% by weight.

Acidity in the first composition may be achieved by formulating with aperoxide such as hydrogen peroxide, inorganic acids such as phosphoric,hydrochloric, nitric or boric acids, and organic C₂-C₂₀ carboxylic acidssuch as citric, malic, lactic, alginic, succinic, tartaric and ascorbicacids. Soluble salts may also be employed such as potassium bitartrate,sodium acid citrate, acid phosphate and pyrophosphate salts such asmonosodium phosphate and disodium pyrophosphate. Levels of the acidityinducing substances may range in amounts from about 0.1 to about 20%,preferably from about 0.5 to about 10%, optimally from 1.0 to 8% byweight of the first composition. Hydrogen peroxide and phosphoric acidare the preferred substances.

Among the carriers, water when present may range in amounts from about 1to 95%, preferably from 20 to 60%, optimally from 30 to 50% by weight ofeach of the compositions. Of course some formulations may be anhydrous.

Humectants are usually also present as one of the carriers. Illustrativeof this category are sorbitol, maltitol, mannitol, glycerin andpolyethylene glycols (e.g. Carbowax). Amounts of the humectant may rangefrom 1 to 60%, preferably from about 5 to about 50%, optimally from 10to 40% by weight of each composition.

Abrasives are normally present in toothpastes and some gels. These mayinclude sodium metaphosphate, dicalcium phosphate (which is notconsidered a water-soluble phosphate), calcium pyrophosphate, silica,alumina, chalk, insoluble bicarbonate salts, and mixtures thereof.Amounts of the abrasives may range from about 1 to about 80%, preferablyfrom 5 to 50% by weight of each composition.

Thickeners are a further type of carrier which can be included in thecompositions of this invention. Illustrative thickeners such as sodiumcarboxy-methyl cellulose, hydroxy ethyl cellulose, methyl cellulose,ethyl cellulose, gum tragacanth, gum arabic, gum karaya, sodiumalginate, carrageenan, guar, xanthan gum, Irish moss, starch, modifiedstarch, Carbomers (crosslinked acrylates) and mixtures thereof.Inorganic substances may also be suitable, especially silica aerogelsand magnesium aluminum silicate (e.g. Veegum). Amounts of the thickenermay range from about 0.01 to about 30%, preferably from 0.1 to 20%,optimally from 0.5 to 15% by weight of a composition.

Surfactants are also considered to be within the carrier definition.Surfactants may either be anionic, nonionic, cationic or amphoteric.Most preferred are sodium lauryl sulphate, sodium dodecylbenzenesulphonate and sodium lauryl sarcosinate. Surfactants may be present inan amount from about 0.5 to about 10%, preferably from 0.8 to 5% byweight of a composition.

Gel compositions are structured with substances than can becharacterized as either humectants or surfactants. For instance, atypical gel structurant is a polyoxyethylene-polyoxypropylene copolymersuch as those sold by the BASF Corporation under the trademark Pluronic®F88, F99, F108 and F127. These materials are also known as Poloxamersand employed in amounts from about 5 to about 30%, preferably betweenabout 18 and about 25% by weight of a composition.

Flavors may also be present in the compositions. These flavors may bebased on oils of spearmint and peppermint. Examples of other flavoringmaterials include menthol, clove, wintergreen, eucalyptus and aniseed.Flavors may range in concentration from about 0.1 to about 5% by weightof a composition.

Sweetening agents may also be included such as saccharin, sodiumcyclamate, aspartame, ace-sulfame, xylitol and combinations thereof atlevels from 0.1 to 10% by weight of a composition.

Gel compositions incorporating hydrogen peroxide may include asequestering agent(s) such as a pyrophosphate or other phosphate forchelation of ferric/ferrous ion as well as other transition metal ionsto enhance hydrogen peroxide stability. The sequestering agents may alsobe included within the paste compositions and are present in amountsfrom about 0.01 to about 20% by weight of a composition. Most preferredchelatants are tetrasodium pyrophosphate, sodium tripolyphosphate andsodium hexametaphosphate, all known to be effective at lower pH withlittle affinity for calcium ion. Other organic chelating agents such assodium citrate and zinc citrate are also useful.

Other additives may also be incorporated such as preservatives,silicones, other synthetic or natural polymers such as Gantrez S97®,additional anti-tartar actives and antigingivitis actives. Among theadditional anti-tartar agents are included zinc citrate, tetrasodiumpyrophosphate, disodium pyrophosphate, dipotassium pyrophosphate,tetrapotassium pyrophosphate and mixtures thereof. Antigingivitisactives may include thymol, Triclosan, stannous gluconate and mixturesthereof. Amounts of each of the aforementioned ingredients will dependupon their function. Generally each of these substances will range inamounts from about 0.01 to about 20% by weight of a composition.

Except in the operating and comparative examples, or where otherwiseexplicitly indicated, all numbers in this description indicating amountsof material ought to be understood as modified by the word “about”.

The following examples will more fully illustrate the embodiments ofthis invention. All parts, percentages and proportions referred toherein and in the appended claims are by weight of either the first orsecond composition unless otherwise indicated.

EXAMPLE 1

Typical of the present invention is a first composition in the form of agel and a second composition in the form of a paste. Each of theseformulations is held in a separate compartment of a dual-compartmentdispenser similar to that disclosed in U.S. Pat. No. 5,038,963(Pettengill et al.).

INGREDIENT WEIGHT % Gel Composition 1A Glycerin 40.00 Pluronic F-12720.00 Monocalcium Phosphate Monohydrate 1.60 Hydrogen Peroxide (35%Active) 4.285 Phosphoric Acid 0.40 FD&C Blue No. 1 0.01 Water BalancePaste Composition 1B Polyol II (70% Sorbitol) 47.00 Syloid 63XX(Hydrated Silica) 15.00 Sodium Bicarbonate 10.00 Sylox 15X 6.00Polyethylene Glycol 1450 (PEG-32) 5.00 Ethyl Alcohol 38B 2.84 SodiumLauryl Sulphate 2.98 Flavor 1.10 Cellulose Gum 0.80 Sodium Saccharin0.54 Menthol 0.50 Sodium Fluoride 0.44 Titanium Dioxide 0.30 WaterBalance

EXAMPLE 2

Another system typical of the present invention is a two parttoothpaste. Each part is placed in a dual-compartment dispenser similarto that of Example 1.

PASTE 2A PASTE 2B COMPONENTS (% WEIGHT) (% WEIGHT) Sorbitol 70% Active28.50  — Syloid 63XX (Hydrated Silica) 20.00  18.0 Glycerin 28.00  32.0Monocalcium Phosphate 6.49 — Citric Acid 5.00 — Syloid 244 (ThickeningSilica) 3.00 0.5 Xanthan Gum 0.50 — Sodium Fluoride — 0.44 FD&C Blue No.1 0.01 — Sodium Bicarbonate — 25.0 Sodium Lauryl Sulphate — 1.5 SodiumCarboxymethyl Cellulose — 0.8 Flavor — 1.0 Titanium Dioxide — 0.4 SodiumSaccharin — 0.2 Water balance balance

The pH of Paste 2A is approximately 2.0. Paste 2B has a pH ofapproximately 9.0. Strips of each of these are extruded onto atoothbrush. These strips are then brushed against the teeth therebymixing them together.

EXAMPLE 3

Yet another system typical of the present invention is a two parttoothpaste as described below. Each part is placed in a dual-compartmentdispenser similar to that of Example 1.

PASTE 3A PASTE 3B COMPONENTS (% WEIGHT) (% WEIGHT) Sorbitol (70% Active)30.50  — Alumina 20.00  18.0 Polyol II 10.00  32.0 Malic Acid 5.00 —Monocalcium Phosphate 4.50 — Syloid 244 (Thickening Silica) 3.00 0.5Xanthan Gum 0.50 — Sodium Fluoride — 0.44 FD&C Blue No. 1 0.01 — SodiumBicarbonate — 25.0 Sodium Lauryl Sulphate — 1.5 Sodium CarboxymethylCellulose — 0.8 Flavor — 1.0 Sodium Carbonate — 0.4 Sodium Saccharin —0.2 Water balance balance

The pH of Paste 3A and 3B respectively are approximately 2 and 9. Stripsof each of these pastes are placed onto a toothbrush. These strips arethen brushed against the teeth thereby mixing them together.

EXAMPLE 4

This Example illustrates use of a monolithic calcium and phosphate saltcombination to deliver the water soluble monocalcium phosphatecomponent. Separate gel and paste formulations representing the firstand second compositions of this invention were prepared with thefollowing compositions.

INGREDIENT WEIGHT % Gel Composition 4A Glycerin 40.00  Pluronic F-127 ®20.00  Hydrogen Peroxide (35% Active) 4.29 Calcium Chloride Dihydrate2.10 Dibasic Sodium Phosphate 1.00 Phosphoric Acid (85% Active) 1.50Sodium Citrate 0.53 FD&C Blue No. 1 0.01 Water Balance Paste Composition4B Polyol II (70% Sorbitol) 40.50  Syloid 63XX (Hydrated Silica) 15.00 Sodium Bicarbonate 10.00  Sylox 15X 6.00 Polyethylene Glycol 1450(PEG-32) 3.00 Ethyl Alcohol 38B 2.84 Sodium Lauryl Sulphate 2.98 Flavor1.10 Cellulose Gum 0.80 Sodium Saccharin 0.54 Menthol 0.50 SodiumFluoride 0.44 Titanium Dioxide 0.30 Water Balance

EXAMPLE 5

Yet another system typical of the present invention is a two parttoothpaste as described below. Each part is placed in a dual compartmentdispenser similar to that of Example 1.

INGREDIENT WEIGHT % Gel Composition 5A Glycerin 40.00  Pluronic F-12720.00  Monocalcium Phosphate Monohydrate 3.10 Phosphoric Acid (85%Active) 0.85 Water Balance Paste Composition 5B Polyol II (70% Sorbitol)46.68  Syloid 63XX (Hydrated Silica) 15.00  Sodium Carbonate 6.50 Sylox15X (Hydrated Silica) 6.00 Polyethylene Glycol 1450 (PEG 32) 5.00 EthylAlcohol 38B 2.84 Sodium Lauryl Sulphate 2.98 Flavor 1.00 Cellulose Gum0.80 Sodium Saccharin 0.50 Menthol 0.50 Sodium fluoride 0.44 TitaniumDioxide 0.30 Water Balance The pH of 5A and 5B respectively areapproximately 2.7 and 9.5

EXAMPLE 6

This Example illustrates use of monocalcium phosphate in a Gelcomposition along with Triclosan solubilized in alcohol.

INGREDIENT WEIGHT % Gel Composition 6A Glycerin 40.00  Pluronic F-12720.00  Alcohol SDA 38B 5.00 Monocalcium Phosphate, Monohydrate 1.55Phosphoric Acid (95% Active) 0.45 Hydrogen Peroxide (35% Active) 4.29Irgacare ® MP (Triclosan) 0.67 Water Balance Paste Composition 6B PolyolII 70% Sorbitol 46.68  Syloid 63XX (Hydrated Silica) 15.00  SodiumBicarbonate 10.00  Sylox 15X (Hydrated Silica) 6.00 Polyethylene Glycol1450 (PEG 32) 3.00 Ethyl Alcohol 38B 2.84 Sodium Lauryl Sulphate 2.98Flavor 1.10 Cellulose Gum 0.80 Sodium Saccharin 0.54 Menthol 0.50 SodiumFluoride 0.44 Titanium Dioxide 0.30 Water Balance The pH of 6A and 6Brespectively are approximately 2.7 and 9.2

EXAMPLE 7

Another Example is shown using monocalcium phosphate in a Gelcomposition. Here Triclosan is incorporated into a Paste composition ofelevated pH for eventual combination with the Gel.

INGREDIENT WEIGHT % Gel Composition 7A Glycerin 40.00  Pluronic F-12720.00  Hydrogen Peroxide (35% Active) 4.29 Monocalcium Phosphate,Monohydrate 3.10 Phosphoric Acid (95% Active) 0.85 Water Balance PasteComposition 7B Polyol II 44.93  Syloid 63XX (Hydrated Silica) 30.00 Sodium Carbonate 7.00 Sylox 15X (hydrated Silica) 2.00 Ethyl Alcohol 38B2.84 Sodium Lauryl Sulphate 2.98 Flavor 1.30 Irgacare ® MP (Triclosan)0.55 Sodium Saccharin 0.54 Cellulose Gum 0.80 Menthol 0.50 Sodiumfluoride 0.44 Titanium Dioxide 0.30 Water Balance The pH 7A and 7Brespectively are approximately 2.7 and 9.2

EXAMPLE 8

A clinical trial was conducted to compare the dental product of Example1 with an identical product that did not include monocalcium phosphatemonohydrate. The commercial toothpastes Aim® and Colgate Total® wereused as reference samples, the latter product being a formulationcontaining triclosan.

Protocol for the clinical was as follows. Panelists were carefullyselected to meet a long list of criteria such as exhibiting visibletartar within only 1 to 2 months of a professional cleaning. Tartarpresent on the lingual aspect of the 6 anterior Mandibular teeth wasevaluated according to the Volpe/Manhold Scoring Index. Following aninitial tartar assessment, each panelist received a thorough dentalcleaning. Panelists were then given Aim® toothpaste for use over thefollowing 3 weeks to allow tartar to build. Another tartar evaluationidentified the baseline for a panelist's normal tartar growth rate. Asecond dental prophylaxis was then performed to remove dental tartarrendering the panelists ready to receive the first test product (Example1 with monocalcium phosphate monohydrate). Tartar evaluations were thenconducted after 2 and 3 weeks of product usage. Aim® was then given tothe panelists for a 4 week washout period.

The Mandibular Anterior teeth were then scaled to remove tartar buildupover the washout period. Panelists were next assigned to use ColgateTotal® for the subsequent 3 weeks. Evaluations were again conductedafter the 2 and 3 week usage period. In a further phase of the test, thepanelists were directed to use Aim® for another 4 week washout. Again,the Mandibular Anterior teeth were scaled to remove tartar buildup overthe 4 week washout period. Panelists were then assigned to Example 1where monocalcium phosphate monohydrate was absent (replaced by 2% zinccitrate) for the next 3 weeks. Tartar evaluations were conducted at the2 and 3 week interval. Results of the tests are reported in the Tablebelow.

TABLE I CALCULUS CLINICAL % CALCULUS REDUCTION AFTER 6 WEEKS Aim ®  +5Colgate Total ® −30 Example 1 (Calcium Phosphate) −42 Example 1 (WithoutCalcium −24 Phosphate)

Positive values indicate an increase in calculus. Negative valuesindicate a reduction. Table I reveals that Example 1 containing calciumphosphate had significantly better calculus inhibition performance thanAim®. The better performance is attributed to calcium phosphate whichwhen absent from Example 1 allowed considerable more calculus formation.

EXAMPLE 9

A further study was conducted under a protocol similar to that describedin Example 8 and utilizing some of the earlier data. All three cells ofthe test employed the same paste (sodium bicarbonate) composition asoutlined below.

Paste Composition 9A INGREDIENT WEIGHT % Polyol II (70% Sorbitol) 33.30 Syloid 63XX (Hydrated Silica) 30.00  Sodium Bicarbonate 10.00  Sylox 15X2.00 Polyethylene Glycol 1450 (PEG 32) 5.00 Sodium Lauryl Sulphate 2.98Alcohol 38B 2.84 Flavor 1.30 Cellulose Gum 0.80 Saccharin 0.54 Menthol0.50 Sodium Fluoride 0.44 Titanium Dioxide 0.30 Water Balance

The gel compositions (containing monocalcium phosphate monohydrate) weredifferent for each of the test cells. The formulations are reported inthe Tables below.

Gel Composition 9B-9D WEIGHT % COMPOSITION 9B 9C 9D Glycerin 40.00 39.0039.00 Pluronic F-127 20.00 21.00 21.00 Hydrogen Peroxide (35% Active)4.285 4.285 4.285 Monocalcium Phosphate Monohydrate — 1.07 — DisodiumPhosphate — 0.20 — Methyl Salicylate 0.50 0.50 0.50 Calcium Chloride — —0.92 Phosphoric Acid (95% Active) 0.15 0.70 0.25 Colorant 0.005 0.010.01 Water Balance Balance Balance

Table II provides the calculus reduction % results.

TABLE II Calculus Reduction Results TEST CALCIUM/PHOSPHATE % CALCULUSFORMULATION (ppm) REDUCTION 9A-B   0.0/3877 −24 9A-C  810/8000 −44 9A-D1250/1380 −40

The study reveals that calcium is essential for a reduction in calculus.Levels of 810 and 1250 ppm calcium in combination with phosphate weresufficient to provide significant calculus reduction.

The foregoing description and examples illustrate selected embodimentsof the present invention. In light thereof variations and modificationswill be suggested to one skilled in the art, all of which are within thespirit and purview of this invention.

What is claimed is:
 1. An anti-tartar dental product comprising: (i) acontainer; (ii) an oral composition stored within the container, thecomposition comprising: (a) a first composition comprising from about0.01 to about 30% by weight of a water-soluble calcium phosphate ormonolithic combination of water soluble calcium and phosphate salts, thecomposition having a pH less than 7; and (b) a second compositionincluding from about 0.01 to about 30% by weight of an alkaline materialand an anti-caries effective amount of a fluoride ion source, the secondcomposition having a pH greater than 7.5 and stored separately from thefirst composition in a manner to avoid contact between the phosphate andthe alkaline material.
 2. The product according to claim 1 wherein thewater-soluble phosphate salt is monocalcium hydrogen phosphate.
 3. Theproduct according to claim 1 wherein the alkaline material is selectedfrom the group consisting of sodium bicarbonate, potassium bicarbonate,sodium hydroxide, potassium hydroxide, sodium carbonate, potassiumcarbonate, calcium carbonate, calcium oxide and mixtures thereof.
 4. Theproduct according to claim 1 wherein the pH of the first compositionranges from 2.5 to 5.5.
 5. The product according to claim 1 wherein thepH of the second composition ranges from 7.2 to
 11. 6. The productaccording to claim 1 wherein the pH of the first composition resultsfrom inclusion of a compound selected from the group consisting ofhydrogen peroxide, inorganic acids, C₂-C₂₀ carboxylic acids and mixturesthereof.
 7. The product according to claim 1 wherein the monolithiccombination of water soluble calcium salts are selected from the groupconsisting of calcium chloride, calcium sulphate and calcium acetate andthe respective phosphate salts are selected from the group consisting ofsodium phosphate, ammonium phosphate and sodium ammonium phosphate. 8.The product according to claim 1 further comprising from about 0.01 toabout 20% by weight of triclosan.
 9. The product according to claim 1further comprising from about 0.01 to about 20% by weight of a zincsalt.
 10. The product according to claim 1 further comprising from about0.01 to about 5% by weight of a fluoride compound.
 11. A method forcontrolling dental tartar comprising (i) obtaining a product whichcomprises: (a) a first composition comprising from about 0.01 to about30% by weight of a water-soluble calcium phosphate or monolithiccombination of water soluble calcium and phosphate salts, thecomposition having a pH less than 7; and (b) a second compositioncomprising from about 0.01 to about 30% by weight of an alkalinematerial and an anti-caries effective amount of a fluoride ion source,the second composition having a pH greater than 7.5 and storedseparately from the first composition in a manner to avoid contactbetween the phosphate and the alkaline material; (ii) extruding aportion of first and second compositions onto a toothbrush; and (iii)brushing the teeth with the combination of first and secondcompositions.
 12. The method according to claim 11 wherein thewater-soluble phosphate salt is monocalcium hydrogen phosphate.
 13. Themethod according to claim 11 wherein the alkaline material is selectedfrom the group consisting of sodium bicarbonate, potassium bicarbonate,sodium hydroxide, potassium hydroxide, sodium carbonate, potassiumcarbonate, calcium carbonate, calcium oxide and mixtures thereof. 14.The method according to claim 10 wherein the pH of the first compositionranges from 2.5 to 5.5.
 15. The method according to claim 10 wherein thepH of the second composition ranges from 7.2 to
 11. 16. The methodaccording to claim 11 wherein the pH of the first composition resultsfrom inclusion of a compound selected from the group consisting ofhydrogen peroxide, inorganic adds, C₂-C₂₀ carboxylic acids and mixturesthereof.
 17. The method according to claim 11 wherein the monolithiccombination of water soluble calcium salts are selected from the groupconsisting of calcium chloride, calcium citrate, calcium sulphate andcalcium acetate and the respective phosphate salts are selected from thegroup consisting of sodium phosphate, ammonium phosphate and sodiumammonium phosphate.
 18. The method according to claim 11 furthercomprising from about 0.01 to about 20% by weight of triclosan.
 19. Themethod according to claim 11 further comprising from about 0.01 to about20% by weight of a zinc salt.